- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07307105
Comparative Effects Of Creative Movement & Play Based Interventions On Motor Skills
Comparative Effects Of Creative Movement & Play Based Interventions On Motor Skills, Balance And Quality Of Life In Children With Developmental Delay
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Punjab Province
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Lahore, Punjab Province, Pakistan, 42000
- Rax clinic iqbal town
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
inclusion Criteria
- Children aged 5-8 years.
- Both girls and boys .
- Mini-Mental State Examination (MMSE) score > 24 .
- Stork Stand Balance Test (both legs) > 4 seconds .
- Pediatric Berg Balance Scale score ≥ 40 .
- TGMD-2 GMQ score ≤ 79 (≤ 25th percentile) .
- BOT-2 Total Motor Composite score ≤ 18th percentile .
- PedsQL total score ≤ 70
Exclusion criteria:
- Musculoskeletal Impairments affecting posture.
- balance.
- Uncorrected visual or auditory impairments .
- Behavioral or Attention Disorders that may impair test compliance or affect performance reliability .
- Recent Surgery or Injury in the past 6 months .
- Use of Assistive Devices .
- Chronic Illness Affecting Physical Activity .
- Participation in specialized motor training in the past 3 months .
- Inability to follow instructions or complete assessments (TGMD-2, BOT-2, PedsQL).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Creative Movement intervention group.
Group A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination,
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Group A (Creative Movement) engaged in activities such as a Hello Song for upper limb coordination, strength exercises (Grow Strong segment), locomotor games, yoga with breathing, and music-making with instruments.
Each session lasted 60 minutes and was conducted twice weekly for 8 weeks
|
|
Experimental: Play-Based intervention group
Group B (Play-Based Intervention) included obstacle courses, dual-limb coordination games, story reading, building tasks (blocks/LEGOs), and arts & crafts for fine motor development.
Each session concluded with a cool-down, promoting relaxation and emotional regulation
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Group B (Play-Based Intervention) included obstacle courses, dual-limb coordination games, story reading, building tasks (blocks/LEGOs), and arts & crafts for fine motor development.
Each session concluded with a cool-down, promoting relaxation and emotional regulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PedsQL.
Time Frame: 8 weeks
|
Is a standardized, validated tool designed to measure health-related quality of life (HRQOL) in children and adolescents aged 2-18 years. The Turkish validity and reliability tests of the form were performed by Memik et al. (2008). There are other versions of this data collection tool which were developed for different age groups. There is a Likert type answer scale with five answer options: (0 ¼ never, 1 ¼ seldom, 2 ¼ sometimes, 3 ¼ often, 4 ¼ always). The points which are obtained from the items are calculated and a score between 0 and 100 is linearly obtained (0 ¼ 100, 1 ¼ 75, 2 ¼ 50, 3 ¼ 25, 4 ¼ 0). A score between 0 and 100 indicates the quality of life score and an increase in the scores means an increase in the quality of life. |
8 weeks
|
|
Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) for fine and gross Motor Skills
Time Frame: 8 weeks
|
Is a widely recognized and reliable tool for evaluating both fine and gross motor skills in children aged 4 to 21 years.
The shorter form of the test consists of fourteen subtests, which assess fine motor precision and integration, bilateral coordination, balance, running speed, agility, upper body coordination, and strength.
The reliability of all the mentioned items is above 0.70, with overall internal consistency reliability ranging from 0.80 to 0.90, and test-retest reliability reported between 0.80 and 0.87, indicating strong measurement stability.
It should be noted that the test validity and reliability were established in a sample of healthy children.
The short form includes five fine motor skill tests (Drawing, Lines through Paths-Crooked, Folding Paper, Copying a Square, Copying a Star, Transferring Pennies) and nine gross motor tasks (Jumping in Place-Same Sides Synchronized, Tapping Feet and Fingers-Same Sides Synchronized, Walking Forward on a Line, Standing on
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Balance Scale PBS for Functional Balance
Time Frame: 8 weeks
|
Is an adaptation of the Berg Balance Scale and it is a criterion-referenced test assessing functional balance in children 2 years - 7 years and older.
It is a valid and reliable balance tool that assesses for functional balance using 14 tasks which are similar to activities of daily living.
Within the tasks, the PBS incorporates the conditions similar to the Romberg, Sharpened Romberg, Functional Reach Test and Standing on One Leg test.
These tasks can be scored from 0 to 4 where a high score indicates good performance and the test can be completed in approximately 20 min with the aid of easily accessible equipment e.g., chair, bench, stopwatch etc.
The PBS has an interrater reliability of (ICC [3, 2] = 0.90-0.92),
test-retest (ICC [2,1] = 0.923), and intra-rater reliability (ICC [2,1] = 0.895-0.998)
allowing for adequately identifying children with balance dysfunction
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Khadija Liaquat, MS, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Communication Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Learning Disabilities
- Therapeutics
- Complementary Therapies
- Psychotherapy
- Behavioral Disciplines and Activities
- Sensory Art Therapies
- Play Therapy
Other Study ID Numbers
- Riphah IU Yashma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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